BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX

    MDR report key: 948424 · Received November 7, 2007

    Report

    Report Number
    948424
    Event Type
    Malfunction
    Date Received
    November 7, 2007
    Date of Event
    November 6, 2007
    Report Date
    November 7, 2007
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING A MIDAS REX DRILL. SUDDENLY, THE MIDAS REX DRILL STARTED TO MAKE A LOUD NOISE. THE HOSE THAT CONNECTS THE HAND PIECE TO THE FOOT PEDAL POPPED. THE MIDAS REX DRILL WAS SUBSTITUTED WITH ANOTHER ONE, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. MANUFACTURER RESPONSE FOR DRILL, SYSTEM, MIDAS REX JUST RETURNED TO VENDOR TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX DRILL, SURGICAL HBB MEDTRONIC MIDAS REX PM100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR